NCT01794520: Phase 1/2: Study Evaluating ABT-199 in Participants With Relapsed or Refractory MM
Updated: Jun 15, 2022
NCT01794520: Phase 1/2: Study Evaluating ABT-199 in Participants With Relapsed or Refractory Multiple Myeloma
The phase 1 primary objectives of this study are to assess the safety profile, characterize pharmacokinetics (PK) and determine the dosing schedule, maximum tolerated dose (MTD), and recommended phase 2 dose (RPTD) of ABT-199 (venetoclax) when administered in participants with relapsed or refractory multiple myeloma. This study will also assess the safety profile and PK of venetoclax in combination with dexamethasone in participants with t(11;14)-positive multiple myeloma.
The phase 2 primary objective is to further evaluate the objective response rate (ORR) and very good partial response or better rate (VGPR+) in participants with t(11;14)-positive multiple myeloma.
Sponsor
AbbVie
Collaborator
Genentech, Inc.
Multiple Locations
International Study
ClinicalTrials.gov Identifier: NCT01794520
Official Title: A Phase I/II Study Evaluating the Safety and Pharmacokinetics of ABT-199 in Subjects With Relapsed or Refractory Multiple Myeloma
First Posted : February 20, 2013
Click here for details on Clinical Trials.gov
Drug: Dexamethasone
Drug: ABT-199
ABT-0199
ABT-199
ABT199
GDC-0199
RG7601
Venclexta
Venclyxto
Venetoclax
VENETOCLAX
Bcl-2 inhibitor GDC-0199
Venclexta
Blood; 2017 Nov
Efficacy of venetoclax as targeted therapy for relapsed/refractory t(11;14) multiple myeloma
Venetoclax is a selective, orally bioavailable BCL-2 inhibitor that induces cell death in multiple myeloma (MM) cells, particularly in those harboring t(11;14), which express high levels of BCL-2 relative to BCL-XL and MCL-1. In this phase 1 study, patients with relapsed/refractory MM received venetoclax monotherapy....
Click here for details
Br J Haematol; 2020
Real-world data on safety and efficacy of venetoclax-based regimens in relapsed/refractory t(11;14) multiple myeloma
The treatment for relapsed/refractory multiple myeloma (RRMM) continues to be challenging despite recent therapeutic advancements. Venetoclax, an inhibitor of the anti-apoptotic protein BCL-2, is a promising agent, especially in patients harbouring t(11;14). Our objective was to review our experience with venetoclax-based regimens at our institution. All ten RRMM patients treated with venetoclax were included and had a median of six prior lines of therapy. The overall response rate was 78% and one patient with cardiac amyloidosis and MM achieved a cardiac organ response. Haematologic toxicities requiring red blood cell and platelet transfusion and non-haematologic toxicities, most commonly gastrointestinal upset, were observed.
Am J Hematol;. 2021
Targeting BCL-2 with venetoclax and dexamethasone in patients with relapsed/refractory t(11;14) multiple myeloma
Venetoclax (Ven) is a selective small-molecule inhibitor of BCL-2 that exhibits antitumoral activity against MM cells with t(11;14) translocation. We evaluated the safety and efficacy of Ven and dexamethasone (VenDex) combination in patients with t(11;14) positive relapsed/refractory (R/R) multiple myeloma (MM).
Locations
United States, Arizona
United States, Arkansas
United States, Connecticut
United States, Georgia
United States, Illinois
United States, Louisiana
United States, Massachusetts
United States, Michigan
United States, Minnesota
United States, Mississippi
United States, Missouri
United States, Nebraska
United States, New Jersey
United States, North Carolina
United States, Ohio
United States, South Dakota
United States, Texas
United States, Washington
United States, Wisconsin
Belgium
France
Norway